GSK 2132231A Antigen-Specific Cancer Immunotherapeutic as Adjuvant Therapy in Patients With Resected Melanoma
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 1,351
- 试验地点
- 1
- 主要终点
- Disease Free Survival (DFS)
研究概览
简要总结
The purpose of this clinical trial is to evaluate the benefit of the immunotherapeutic product GSK 2132231A in preventing disease relapse when given to melanoma patients, after surgical removal of their tumor.
This Protocol Posting has been updated following Amendments 1 of the Protocol, March 2010. The impacted sections are outcome measures and entry criteria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent signed.
- •Male or female patient with histologically proven stage IIIB or IIIC cutaneous melanoma presenting with macroscopic lymph node involvement suitable for surgery.
- •The patient must have been surgically rendered free of disease before the randomization.
- •Patient is ≥ 18 years old at the time of signing the informed consent form.
- •The patient's lymph node tumor shows expression of the MAGE-A3 gene.
- •The patient has fully recovered from surgery.
- •ECOG performance status of 0 or 1 at the time of randomization.
- •The patient must have adequate organ functions as assessed by standard laboratory criteria.
- •If the patient is female, she must be of non-childbearing potential, or practice adequate contraception.
- •In the opinion of the investigator, the patient can and will comply with all the requirements of the protocol.
排除标准
- •The patient suffers from a mucosal or ocular melanoma.
- •The patient has or has had any history of in-transit metastases
- •The patient has been treated or is scheduled to be treated with an adjuvant anticancer therapy after the surgery that qualifies the patient for inclusion in the present trial.
- •The patient requires concomitant chronic treatment with systemic corticosteroids or any other immunosuppressive agents.
- •Use of any investigational or non-registered product (drug or vaccine) other than the study treatment.
- •The patient has a history of autoimmune disease.
- •The patient has a family history of congenital or hereditary immunodeficiency.
- •The patient is known to be positive for Human Immunodeficiency Virus (HIV) or has another confirmed or suspected immunosuppressive or immunodeficient condition.
- •History of allergic disease or reactions likely to be exacerbated by any component of the treatments.
- •The patient has psychiatric or addictive disorders that may compromise his/her ability to give informed consent or to comply with the trial procedures.
- •The patient has concurrent severe medical problems, unrelated to the malignancy, that would significantly limit full compliance with the study or expose the patient to unacceptable risk.
- •The patient has previous or concomitant malignancies at other sites, except effectively treated non-melanoma skin cancers or carcinoma in situ of the cervix or effectively treated malignancy that has been in remission for over 5 years and is highly likely to have been cured.
- •The patient has an uncontrolled bleeding disorder.
- •For female patients: the patient is pregnant or lactating.
研究组 & 干预措施
MAGE-A3 Group
Patients who received up to 13 doses of recMAGE-A3 + AS15 ASCI. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of ASCI product at 3-week intervals, followed by 8 doses of ASCI product at 12-week intervals.
干预措施: GSK 2132231A (Drug)
Placebo Group
Patients who received up to 13 doses of placebo. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of placebo at 3-week intervals, followed by 8 doses of placebo at 12-week intervals.
干预措施: Placebo (Drug)
结局指标
主要结局
Disease Free Survival (DFS)
时间窗: At follow-up analysis (up to Year 5)
DFS = time to event from randomization to the date of first disease recurrence (as assessed by investigator) or the date of death (whatever cause), whichever occurred first. DFS was expressed as the person-year rate i.e. the number of patients with at least one event (n) over the sum of the follow-up periods in years (T), until the first occurrence of a recurrence/death. Types of recurrence to be considered as an event included loco-regional and distant metastases. Any death occurring without prior documentation of tumor recurrence was considered as an event (not censored in the stat. analysis) as this approach was less prone to introduce bias. If no event occurred by the time of analysis, then the time to event was censored at the last assessment date (tumor assessment/visit) of the patient. Any new primary cancer at another site, including second primary melanoma, was not considered as a recurrence and had to be reported as a Serious Adverse Event (SAE).
次要结局
- Overall Survival (OS)(At Final analysis (Month 30 = Year 2.5) and at follow-up analysis (up to Year 5))
- Disease-free Specific Survival (DFSS)(At Final analysis (Month 30 = Year 2.5))
- Distant Metastasis-free Survival (DMFS)(At Final analysis (Month 30 = Year 2.5))
- Number of Subjects With Abnormal Haematological and Biochemical Parameters(Within the 31-day (Days 0-30) post-treatment period)
- Number of Subjects With Any Serious Adverse Events (SAEs)(From Day 0 up to study end (up to 5 years))
- Number of Subjects With Potential Immune-mediated Diseases (pIMDs)(From Day 0 up to study end (up to 5 years))
- Health-related Quality of Life(At Weeks 0, 6, 12 [on the day of and the day after treatment administration (TA)], at Month 6, 9, 12, 24, at the Concluding visit (Month 30) + 6 months and +12 Months and at disease recurrence)
- Anti-MAGE-A3 Antibody Geometric Mean Concentrations(At Weeks 0, 6, 12, 36, 48 72, 120 (Concluding visit) and at Month 120 + 6 months)
- Number of Subjects With Anti-MAGE-A3 Antibody Response(At Weeks 6, 12, 36, 48 72, 120 (Concluding visit) and at Month 120 + 6 months)
- Number of Subjects With Anti-MAGE-A3 Antibody Concentrations Above the Cut-off Value(At Weeks 0, 6, 12, 36, 48 72, 120 (Concluding visit) and at Week 120 + 6 months)
- Number of Subjects With Any Adverse Events (AEs)(Within the 31-day (Days 0-30) follow-up period after treatment)